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Bioequivalence Study of Torrent Pharmaceutical Limited's Venlafaxine Hydrochloride ER Capsules Under Fed Conditions

NCT01418612 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2011-08-17

No results posted yet for this study

Summary

Objective:

The Bioequivalence studies were performed to compare the rate and extent of release of the drug substance from the two Capsule formulations containing Venlafaxine Hydrochloride Extended-Release Capsules 150mg of Torrent Pharmaceuticals Limited and the Effexor XR® (Venlafaxine Hydrochloride) Extended-Release Capsules 150mg of Wyeth Pharmaceuticals Inc., USA.

Study Design:

Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India) Versus Effexor XR® 150mg capsule (Reference formulation, Wyeth Pharmaceuticals Inc., USA) in Healthy Volunteers

Conditions

  • Healthy

Interventions

DRUG

Venlafaxine Hydrochloride Extended-Release Capsules of Torrent Pharmaceuticals Limited

Sponsors & Collaborators

  • Torrent Pharmaceuticals Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418612 on ClinicalTrials.gov